ANDA 203030

UNICHEM LABS LTD

FDA Drug Application

Application #203030

Documents

• Letter: 2015-10-21

Application Sponsors

ANDA 203030

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	25MG	0	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM
002	TABLET;ORAL	50MG	0	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM
003	TABLET;ORAL	100MG	0	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-10-14
LABELING; Labeling	SUPPL	4	AP	2019-05-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-10-03	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	4	Null	15
SUPPL	7	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203030
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/14\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203030Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/07\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/10\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-07
        )

)